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Analysis of HIV-1 Replication During Antiretroviral Therapy

18 Years
Open (Enrolling)
HIV Infection

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Trial Information

Analysis of HIV-1 Replication During Antiretroviral Therapy

Combination antiretroviral therapy for human immunodeficiency virus serotype 1 (HIV-1)
infection has resulted in profound reductions in viremia and is associated with marked
improvements in morbidity and mortality. Therapy is not curative, however, and prolonged
therapy is complicated by drug toxicity and the emergence of drug resistance. How drug
resistance emerges during suppressive antiretroviral therapy remains poorly understood.
Investigating the characteristics of HIV-1 replication during suppressive antiretroviral
therapy will yield important insights in understanding the emergence resistance, and
requires patients who have suppressed viral RNA levels. Prior National Institutes of Health
(NIH) protocols have made important observations regarding the kinetics of HIV-1 decline in
response to therapy, the levels of HIV-1 viremia during suppressive therapy, and the nature
of HIV-1 genetic diversity prior to and following initiation of antiretroviral therapy. In
the process, these studies have generated a useful cohort of patients with suppressed viral
RNA levels, who have been extensively characterized from a virologic and immunologic
standpoint. Similarly, patients from other NIH protocols have been followed for prolonged
periods before and after therapy has been initiated, and they also have stored sample sets
that would be useful in new studies of HIV replication. The HIV Drug Resistance Program
(DRP) has studied samples from protocols 00-I-0110 and 97-I-0082 to develop a number of new,
sensitive laboratory techniques to measure and quantitate genetic variation and to
investigate immune response parameters. To further advance understanding of HIV-1
replication during suppressive antiretroviral therapy and the emergence of drug resistance,
we propose a new protocol to study these 2 patient cohorts (from the above cited protocols)
and selected patients in other protocols with a new series of studies. The primary objective
of this protocol is to investigate the virologic and immunologic characteristics of
HIV-infected individuals undergoing antiretroviral therapy. Upon implementation, this new
protocol will provide human subjects protection for samples collected under the two prior
protocols, whether patients enroll in the new study or not.

Inclusion Criteria


Inclusion criteria for this protocol comprise all of the following conditions:

- Age greater than or equal to 18 years.

- HIV infection with documented reactive ELISA and positive western blot.

- Prior enrollment in 00-I-0110, 97-I-0082 OR patients with long term evaluation at NIH
for whom additional sampling will be useful for protocol objectives, including:

- Available stored specimens from pretherapy period.

- Ongoing suppression of viremia with bDNA less than 50 copies/mL, OR

- Suppression of viremia to less than 50 copies/mL followed by rebound viremia
during therapy.

- Patients must have a private physician for routine medical care.


Any prospective study subject who has been previously withdrawn from any prior study for
inability to comply with study procedures will be considered ineligible for this study.

Type of Study:


Study Design:

Time Perspective: Prospective

Outcome Measure:

Relationship of HIV-1 RNA levels and genetic variation in patients on antiretroviral therapy.

Principal Investigator

Frank Maldarelli, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)


United States: Federal Government

Study ID:




Start Date:

September 2008

Completion Date:

Related Keywords:

  • HIV Infection
  • HIV
  • Antiretrovial Therapy
  • Viremia
  • Genetic Analysis
  • Single Copy Assay
  • HIV Infections
  • Acquired Immunodeficiency Syndrome



National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, Maryland  20892