Early H.I.V. Therapy Sharply Curbs Transmission

By DONALD G. McNEIL Jr.

People infected with the virus that causes AIDS are far less likely to infect their sexual partners if they are put on treatment immediately instead of waiting until their immune systems begin to deteriorate, according to preliminary results from a large clinical trial released Thursday.

Patients with H.I.V. were 96 percent less likely to pass on the infection if they were taking antiretroviral drugs — a finding that is so overwhelming that it is likely to change the way American AIDS doctors treat patients and what treatment policies are adopted by the World Health Organization and other countries, said Dr. Anthony S. Fauci, head of the National Institute of Allergy and Infectious Diseases, which paid for the trial.

The data was so convincing that the trial, scheduled to last until 2015, is effectively being ended early.

There have been previous studies, notably among drug abusers in San Francisco and Vancouver, British Columbia, that concluded that starting patients on drugs immediately would stop them from infecting others.

Those studies led Unaids, the United Nations AIDS-fighting agency, to adopt “test and treat” as its goal last year; the policy encourages doctors to start people on treatment as soon as they test positive for H.I.V. However, this is the first evidence from a randomized clinical trial, the gold standard in medical research.

AIDS prevention specialists not connected to the trial were enthusiastic.

“These results are phenomenal,” said Thomas J. Coates, director of the global health program at the University of California, Los Angeles, and the founder of the Center for AIDS Prevention Studies in San Francisco. “It was a tough study to do, and I’m thrilled it came out this way.”

Dr. Julio Montaner, an AIDS specialist at the University of British Columbia whose work among Vancouver heroin addicts helped lead to the Unaids policy, called the result of 96 percent protection “as good as it gets.”

“This is consistent with what we’ve been saying and doing in British Columbia for close to a decade,” he said. “How much more evidence do we need before we implement what we know works?”

The $73 million trial, known as HPTN 052, involved 1,763 couples in 13 cities on four continents. One member of each couple was infected with H.I.V.; the other was not. In half the couples, chosen at random, the infected partner was put on antiretroviral drugs as soon as he or she tested positive for the virus.

In the other half, the infected person started treatment only when his or her CD4 count — a measure of the immune system’s strength — dropped below 250 per cubic millimeter.

In 28 of the couples, the uninfected person became infected with the partner’s strain of the virus. Twenty-seven of those 28 infections took place in couples in which the partner who was infected first was not yet getting treatment.

On Thursday, Dr. Fauci and Dr. Myron Cohen, an AIDS specialist from the University of North Carolina at Chapel Hill and the study’s director, announced that the data collected since the study began in 2005 had been “unblinded” to an independent safety review panel, which is standard procedure in clinical trials. When the panel realized how much protection early treatment afforded, it recommended that drug regimens be offered to all participants. Although participants will still be followed, the trial is effectively over because it will no longer be a comparison between two groups on different regimens.

The results carry moral implications for doctors in the United States. Although medical associations like the Infectious Diseases Society of America advocate starting patients on AIDS drugs early, the decision is made by the doctor and patient. Some patients fear the reported side effects of AIDS drugs and want to delay taking the drugs until they get obviously sick or until their CD4 counts fall, and some doctors go along with that, Dr. Fauci said, especially as long as their patients’ CD4 counts remain above 350.

But that means the patient may infect others during the delay. Of the 27 people in the study who became infected while their partners were not yet taking the drugs, 17 had partners whose CD4 counts were still above 350.

Asked if it could now be considered immoral for a doctor to accede to a patient’s request to delay starting drugs, Dr. Fauci said: “I’m not going to go there. I’m not going to say it’s immoral. But there is more and more data showing the advantages of starting as early as you can.”

Dr. Coates of U.C.L.A. said he hoped that treatment delays would fade away because the newest antiretroviral drugs had few side effects.

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By CARL HULSE

WASHINGTON — The Senate on Saturday voted to strike down the ban on gay men and lesbians serving openly in the military, bringing to a close a 17-year struggle over a policy that forced thousands of Americans from the ranks and caused others to keep secret their sexual orientation.

By a vote of 65 to 31, with eight Republicans joining Democrats, the Senate approved and sent to President Obama a repeal of the Clinton-era law, known as “don’t ask, don’t tell,” a policy critics said amounted to government-sanctioned discrimination that treated gay, lesbian and bisexual troops as second-class citizens.

Mr. Obama hailed the action, which fulfills his pledge to reverse the ban, and said it was “time to close this chapter in our history.”

“As commander in chief, I am also absolutely convinced that making this change will only underscore the professionalism of our troops as the best-led and best-trained fighting force the world has ever known,” he said in a statement after the Senate, on a preliminary 63-to-33 vote, beat back Republican efforts to block final action on the repeal bill.

The vote marked a historic moment that some equated with the end of racial segregation in the military.

It followed an exhaustive Pentagon review that determined the policy could be changed with only isolated disruptions to unit cohesion and retention, though members of combat units and the Marine Corps expressed greater reservations about the shift. Congressional action was backed by Pentagon officials as a better alternative to a court-ordered end.

Supporters of the repeal said it was long past time to abolish what they saw as an ill-advised practice that cost valuable personnel and forced troops to lie to serve their country.

“We righted a wrong,” said Senator Joseph I. Lieberman, the independent from Connecticut and a leader of the effort to end the ban. “Today we’ve done justice.”

Before voting on the repeal, the Senate blocked a bill that would have created a path to citizenship for certain illegal immigrants who came to the United States at a young age, completed two years of college or military service and met other requirements including passing a criminal background check.

The 55-to-41 vote in favor of the citizenship bill was five votes short of the number needed to clear the way for final passage of what is known as the Dream Act.

The outcome effectively kills it for this year, and its fate beyond that is uncertain since Republicans who will assume control of the House in January oppose the measure and are unlikely to bring it to a vote.

The Senate then moved on to the military legislation, engaging in an emotional back and forth over the merits of the measure as advocates for repeal watched from galleries crowded with people interested in the fate of both the military and immigration measures.

“I don’t care who you love,” Senator Ron Wyden, Democrat of Oregon, said as the debate opened. “If you love this country enough to risk your life for it, you shouldn’t have to hide who you are.”

Mr. Wyden showed up for the Senate vote despite saying earlier that he would be unable to do so because he would be undergoing final tests before his scheduled surgery for prostate cancer on Monday.

The vote came in the final days of the 111th Congress as Democrats sought to force through a final few priorities before they turn over control of the House of Representatives to the Republicans in January and see their clout in the Senate diminished.

It represented a significant victory for the White House, Congressional advocates of lifting the ban and activists who have pushed for years to end the Pentagon policy created in 1993 under the Clinton administration as a compromise effort to end the practice of barring gay men and lesbians entirely from military service.

Saying it represented an emotional moment for members of the gay community nationwide, advocates who supported repeal of “don’t ask, don’t tell” exchanged hugs outside the Senate chamber after the vote.

“Today’s vote means gay and lesbian service members posted all around the world can stand taller knowing that ‘don’t ask, don’t tell’ will soon be coming to an end,” said Aubrey Sarvis, an Army veteran and executive director for Servicemembers Legal Defense Network.

Senator John McCain, Republican of Arizona and his party’s presidential candidate in 2008, led the opposition to the repeal and said the vote was a sad day in history.

“I hope that when we pass this legislation that we will understand that we are doing great damage,” Mr. McCain said. “And we could possibly and probably, as the commandant of the Marine Corps said, and as I have been told by literally thousands of members of the military, harm the battle effectiveness vital to the survival of our young men and women in the military.”

He and others opposed to lifting the ban said the change could harm the unit cohesion that is essential to effective military operations, particularly in combat, and deter some Americans from enlisting or pursuing a career in the military. They noted that despite support for repealing the ban from Defense Secretary Robert M. Gates and Adm. Mike Mullen, chairman of the Joint Chiefs of Staff, other military commanders have warned that changing the practice would prove disruptive.

“This isn’t broke,” Senator James M. Inhofe, Republican of Oklahoma, said about the policy. “It is working very well.”

Other Republicans said that while the policy might need to be changed at some point, Congress should not do so when American troops are fighting overseas.

Only a week ago, the effort to repeal the “don’t ask, don’t tell” policy seemed to be dead and in danger of fading for at least two years with Republicans about to take control of the House. The provision eliminating the ban was initially included in a broader Pentagon policy bill, and Republican backers of repeal had refused to join in cutting off a filibuster against the underlying bill because of objections over limits on debate of the measure.

In a last-ditch effort, Mr. Lieberman and Senator Susan Collins of Maine, a key Republican opponent of the ban, encouraged Democratic Congressional leaders to instead pursue a vote on simply repealing it. The House passed the measure earlier in the week.

The repeal will not take effect for at least 60 days, and probably longer, while some other procedural steps are taken. In addition, the bill requires the defense secretary to determine that policies are in place to carry out the repeal “consistent with military standards for readiness, effectiveness, unit cohesion, and recruiting and retention.”

“It is going to take some time,” Ms. Collins said. “It is not going to happen overnight.”

In a statement, Mr. Gates said that once the measure was signed into law, he would “immediately proceed with the planning necessary to carry out this change carefully and methodically, but purposefully.” In the meantime, he said, “the current law and policy will remain in effect.”

Because of the delay in formally overturning the policy, Mr. Sarvis appealed to Mr. Gates to suspend any investigations into military personnel or discharge proceedings now under way. Legal challenges to the existing ban are also expected to continue until the repeal is fully carried out.

In addition to Ms. Collins, Republicans backing the repeal were Senators Scott P. Brown of Massachusetts, Richard M. Burr of North Carolina, John Ensign of Nevada, Mark Kirk of Illinois, Lisa Murkowski of Alaska, Olympia J. Snowe of Maine and George V. Voinovich of Ohio.

“It was a difficult vote for many of them,” Ms. Collins said, “but in the end they concluded, as I have concluded, that we should welcome the service of any qualified individual who is willing to put on the uniform of this country.”

Mr. Lieberman said the ban undermined the integrity of the military by forcing troops to lie. He said 14,000 people had been forced to leave the armed forces under the policy.

“What a waste,” he said.

The fight erupted in the early days of President Bill Clinton’s administration and has been a roiling political issue ever since. Mr. Obama endorsed repeal in his presidential campaign and advocates saw the current Congress as their best opportunity for ending the ban. Dozens of advocates of ending the ban — including one severely wounded in combat before being forced from the military — watched from the Senate gallery as the debate took place.

Senator Carl Levin, the Michigan Democrat who is chairman of the Armed Services Committee, dismissed Republican complaints that Democrats were trying to race through the repeal to satisfy their political supporters.

“I’m not here for partisan reasons,” Mr. Levin said. “I’m here because men and women wearing the uniform of the United States who are gay and lesbian have died for this country, because gay and lesbian men and women wearing the uniform of this country have their lives on the line right now.”